To determine the safety of hypofractionated stereotactic radiotherapy (SRT) in patients with advanced hepatocellular carcinoma.

Secondary

To determine the maximum tolerated dose of SRT in these patients.

To determine the objective tumor response rate in terms of the percentage of tumor size change on CT, percentage of intensity change on MRI, and the percentage of change in alfa fetoprotein in patients treated with this therapy.

To determine the value of 4-dimensional CT in liver cancer planning in terms of the extent of liver motion (three dimensionally) and the percentage of patients requiring breath gating due to the amplitude of organ motion exceeding 1 cm in any dimension.

To determine the value of breath gating in liver cancer SRT in terms of the success rate of breath gating and the percentage of treatment time prolongation secondary to the gating.

Measurable disease, defined as ≥ 1 unidimensionally target lesion that can be accurately measured by CT scan or MRI according to RECIST and must have a maximum diameter ≤ 8 cm

No known CNS tumors, including metastatic brain disease

Child-Pugh class A-B cirrhotic status

PATIENT CHARACTERISTICS:

Karnofsky performance status 60-100%

Life expectancy ≥ 12 weeks

WBC ≥ 2,000/μL

Platelet count ≥ 60,000/mm³

Hemoglobin ≥ 8.5 g/dL

INR ≤ 2.3

No malignancy within the past 3 years that is distinct in its primary site or histology from HCC, except for carcinoma in situ of the cervix, treated basal cell carcinoma, or superficial bladder tumors (i.e., Ta, Tis, and T1), or any other cancer that has been curatively treated > 3 years prior to study entry

No renal failure requiring hemodialysis or peritoneal dialysis

No uncontrolled intercurrent illness including, but not limited to, any of the following:

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607828

Locations

United States, Nebraska

UNMC Eppley Cancer Center at the University of Nebraska Medical Center